The Montefiore Metoclopramide Study
Information source: Montefiore Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Extrapyramidal Symptoms
Intervention: metoclopramide (Drug); Diphenhydramine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s):
Benjamin W Friedman, MD, Principal Investigator, Affiliation: Montefiore Medical Center
Brooke Bender, MD, Study Director, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Overall contact:
Benjamin Friedman, MD, MS, Phone: 718-920-6626, Email: befriedma@montefiore.org
Summary
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea,
vomiting, and migraine headaches in Emergency Departments (EDs). However, little research
has focused on the optimal dose of metoclopramide for treatment of nausea in the ED. We
propose a randomized, double-blind, placebo controlled trial to investigate the optimal
dose of metoclopramide for treatment of nausea.
Clinical Details
Official title: A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide
Study design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Nausea scale
Secondary outcome: Akathisia scale
Detailed description:
The most effective dose of metoclopramide for treatment of nausea in the ED setting has not
been thouroughly investigated. One pilot study among ED patients in Australia found no
statistical difference between 10 mg and 0. 4 mg/kg; another investigation suggests that the
anti-emetic effect of 10 mg of metoclopramide is no more effective than placebo. In
contrast, investigations focusing on chemotherapy patients and post-operative patients
suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting.
This ED study will compare the anti-emetic efficacy of 10 mg and 20 mg metoclopramide by
using the visual analog scale.
In addition to evaluation of dose, we will evaluate one of the most common side affects of
metoclopramide, akathisia. Akathisia is characterized by a subjective component of
restlessness and an objective component in the form of the inability to remain motionless.
Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia
when dopamine function is impaired in the basal ganglia. In fact, the use of
diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a
different anti-emetic, prochlorperazine. However, no research has focused on the use of
anti-cholinergic mediations to reduce MIA. This investigation will assess the use of 25 mg
of diphenhydramine in preventing MIA in ED patients being treated for nausea/vomiting.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- primary or secondary complaints of nausea/vomiting
Exclusion Criteria:
- age 21-65
- pregnancy
- use of anti-histamine or dopamine antagonist as outpatient and/or within last 24
hours of presentation
- previous adverse reaction to study medications
- use of opoid medications prior to study start time within that ED visit
Locations and Contacts
Benjamin Friedman, MD, MS, Phone: 718-920-6626, Email: befriedma@montefiore.org
Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting
Benjamin Friedman, Phone: 718-920-6626
Additional Information
Starting date: May 2007
Last updated: May 16, 2007
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